跳至主要内容
临床试验/NCT06222242
NCT06222242招募中不适用

mychoiceTM Implementation in a Real World Clinical Environment - Delivery and Effectiveness

Fox Chase Cancer Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年6月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Effectiveness

研究概览

简要总结

This is a pragmatic, non-randomized mixed-methods evaluation study designed to evaluate the feasibility and acceptability of delivering the mychoiceTM tool to new Medical Oncology patients as well as to more deeply explore its value to patients in their discussion with their provider about clinical trials as a treatment option over the course of their oncology treatment (Effectiveness).

详细描述

This is a pragmatic, non-randomized mixed-methods evaluation study designed to evaluate the feasibility and acceptability of delivering the mychoiceTM tool to new Medical Oncology patients as well as to more deeply explore its value to patient in their discussion with their provider about clinical trials as a treatment option over the course of their oncology treatment (Effectiveness).

Our goal is to focus this study with patients who have had their first Medical Oncology Appointment based on a nightly EMR feed. The mychoiceTM link (currently mychoice.kevindurr.com, but will change to mychoice.templehealth.org prior to study launch) will be sent to patients through a REDCap feed where they can review the mychoice tool and voluntarily answer a short 5 question quality improvement (QI) survey about their experience with mychoiceTM. The survey will include a question about their willingness to be contacted regarding the more in-depth effectiveness study. This survey data will only be evaluated at an aggregate level and used for process improvement purposes.

The effectiveness study will be conducted with patients who have used mychoiceTM and have agreed to be contacted by Fox Chase Research Staff as indicated in their response to one of the questions in the QI survey. Our goal is to conduct follow-up with those patients who used mychoiceTM to evaluate the impact of the tool on patients' perceived preparedness to discuss clinical trials with their physician and insights into this decision-making process over six-months during their treatment. In addition, we will assess provider and system barriers and facilitators to implementation of mychoice in real world settings to guide future dissemination and implementation.

There are three levels of evaluation questions in this project and specific aims related to each.

  1. Can an evidence-based digital health tool designed to promote discussion about clinical trial participation (mychoiceTM) be easily provided to patients in real time, and will this dissemination approach be acceptable to patients and providers? (Aim 1)
  2. For a sub-set of these patients who use the tool and express interest in participating in a follow-up study evaluation, does the tool positively impact their preparation for a discussion about clinical trials participation across their cancer treatment trajectory? (Aim 3. What are the factors (based on Implementation Research frameworks - RE-AIM and Consolidated Framework Implementation Research) that influence the implementation of mychoiceTM in a real world setting that can guide future dissemination and implementation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •18 years of age or over
  • •Able to speak and read English
  • •Medical Oncology patients who have had their initial visit
  • •Have a cell phone number and/or an email in the electronic medical record

排除标准

  • •Doesn't not speak or read English
  • •Patients who do not have a cancer diagnosis

研究组 & 干预措施

mychoiceTM intervention

Experimental

Single arm study - all participants receive mychoiceTM

干预措施: mychoiceTM (Behavioral)

结局指标

主要结局

Effectiveness

时间窗: 24 months

Assess the effectiveness and value of the mychoiceTM tool on patients' preparation for the discussion about clinical trials through baseline and 4 monthsurveys and interviews with a selected sample at 2 months. The primary outcome will be to measure the effectiveness of the tool using a modified Ottawa Preparation Scale (PrepDM, 1-5 scale) addressing the effectiveness of the tool to prepare for a discussion with their provider. Based on our previous randomized trial, benchmark for success is mean score of 3.5 or higher across all patients enrolled on the PrepDM measures (or a total score of 62.5).

Feasibility to disseminate the mychoice tool to patients

时间窗: 24 months

Assess the feasibility of disseminating the mychoiceTM preparatory tool to all Medical Oncology patients and the acceptability (measured by recommendation to other patients. Patient feasibility will focus on the proportion of patients who receive the mychoiceTM tool and open the web-based intervention (goal 50%).

Acceptability

时间窗: 24

Patient acceptability will be measured for those patients who complete a voluntary, anonymous, feedback survey. Patients will rate how much they would recommend the navigation intervention to other patients on a scale of 1 to 5. Acceptability threshold would be met with a mean score of 3.5 or higher across all patients (aggregated data) who complete the feedback form (QI).

次要结局

  • Implementation Factors(24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Linda Fleisher

Research Professor

Fox Chase Cancer Center

研究点 (1)

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